MAUDE Adverse Event Report: STRYKER NEUROVASCULAR TARGET 360 NANO; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number 1.5MM X 4CM

Device Problem Positioning Failure (1158)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/14/2017

Event Type  malfunction  

Event Description

During cerebral coil embolization procedure, the embolization coil would not deploy.It was then removed and another coil was used.Successful and complete coil embolization of the anterior communicating artery aneurysm was performed.There was no patient impact.Manufacturer response for embolization coil, target 360 nano detachable coil (per site reporter).The rep is arranging a shipper kit to return it to the vendor.

• Brand Name: TARGET 360 NANO
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR; 47900 bayside parkway; fremont CA 94538
• MDR Report Key: 6766938
• MDR Text Key: 81814371
• Report Number: 6766938
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 1.5MM X 4CM
• Device Catalogue Number: 542154
• Device Lot Number: 19638696
• Other Device ID Number: M0035421540
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/20/2017
• Event Location: Hospital
• Date Report to Manufacturer: 07/20/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NOT APPLICABLE.
• Patient Age: 38 YR
• Patient Weight: 210